[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540323":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":38,"responsibleParty":55,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":41,"whyStopped":27,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Universidad Complutense de Madrid","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Collagen matrix","EXPERIMENTAL","a cross-linked volume stable collagen matrix (VCMX; Geistlich Fibro-Gide, Geistlich Pharma AG)",[13],"Procedure: flapless alveolar decortication with augmentation",{"label":15,"type":16,"description":17,"interventionNames":18},"Xenograft","ACTIVE_COMPARATOR","a graft consisting of bovine hydroxyapatite xenograft (Geistlich Bio-Oss; Geistlich Pharma AG), covered by a native collagen membrane (Geistlich Bio-Gide; Geistlich Pharma AG), tagged with pins at the ends.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","flapless alveolar decortication with augmentation","piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane. Piezocisions will be performed using a piezoelectric device.",[9,15],[26],"flapless piezoincision with augmentation",null,[29,34],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Eduardo Montero, Prof","CONTACT","+34 91 3941901","eduardomonterosolis@ucm.es",{"name":35,"role":31,"phone":36,"phoneExt":27,"email":37},"Conchita Martin, Prof","+34 91 3941923","mariacom@ucm.es",[39],{"facility":40,"status":41,"city":42,"state":27,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Faculty of Odontology, University Complutense Madrid","RECRUITING","Madrid","28040","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],-3.70256,40.4165,{"lat":50,"lon":49},[53,54],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},{"name":35,"role":31,"phone":32,"phoneExt":27,"email":37},{"type":56,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[58],{"name":59,"class":6},"Osteology Foundation","100540323","effect-on-periodontal-phenotype-of-flapless-piezoincission-during-orthodontic-treatment-100540323",false,"NCT06315348","Effect on Periodontal Phenotype of Flapless Piezoincission During Orthodontic Treatment","Effect on the Periodontal Phenotype of Flapless Alveolar Decortication and Augmentation During Orthodontic Treatment: A Randomized Clinical Trial","Piezo_Ortho","Inclusion Criteria:\n\nPatients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy.\n\nThe inclusion criteria will be as follows:\n\n* patients requiring maxillary and\u002For mandible orthodontic treatment;\n* patients with permanent dentition in stage 5 or 6 of the cervical vertebral maturation method as described by Baccetti et al. (2002);\n* minimal to moderate maxillary and\u002For mandibular anterior crowding at baseline (arch length discrepancy from 3-8 mm); and\n* adequate oral health (i.e. periodontal health, absence of periapical infections and untreated caries).\n\nExclusion Criteria:\n\n* subjects with periodontitis stage III or IV (Papapanou et al., 2018);\n* subjects with poor oral hygiene (represented as full-mouth plaque scores (FMPS) \\>25%);\n* ongoing chronic drug therapy influencing bone metabolism (e.g. steroids, immunosuppressors or antiresorptive drugs);\n* subjects with uncontrolled systemic diseases (e.g. diabetes);\n* pregnancy and\n* subjects not willing to comply with the study visits","ALL","16 Years","70 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","Research Question\n\nWhile the reduction in treatment times and the patient satisfaction after periodontally accelerated osteogenic orthodontics (PAOO) are well sustained in the scientific literature, there is still controversy regarding if grafting leads to i) change of the periodontal phenotype and ii) greater stability of post-orthodontic treatment outcomes, highlighting the need of controlled clinical trials.\n\nAims of the Project\n\nThe aim of this randomized clinical trial (RCT) is to compare piezocision-assisted orthodontics, concomitant to soft tissue grafting (volume-stable collagen matrix), with piezocision-assisted orthodontics, concomitant to bone grafting with a xenograft and a native collagen membrane, in orthodontic non-growing patients. The primary aim will be to determine the impact of this surgical protocol on the hard and soft tissue changes occurring on the buccal aspect of the dentition. Secondary objectives will include the assessment of the comparative impact on treatment duration, rate of tooth movements, presence of root resorption, periodontal parameters, bone level changes and patient-reported outcome measures (PROMs) between the two groups.",[79,80],"Dental Malocclusion","Maxillary Deficiency",[82,83,84,85],"Periodontal phenotype","Flapless piezoincision","Orthodontic tooth movement","Tissue augmentation","2026-05-04",{"date":88,"type":89},"2026-05-08","ACTUAL",{"date":91,"type":89},"2024-04-20",{"date":93,"type":73},"2026-12",{"name":5,"class":6},1]